# K062382: Clearfil DC Bond

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 27, 2006 after 43 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931812 (1993). 17 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042913: Clearfil Tri-S Bond, Kuraray Medical, Inc. (2004) Summary page 1.
- K012440: Modification to Clearfil Liner Bond 2V, Kuraray Medical, Inc. (2001) Summary page 1.
- K012432: Modification to Clearfil Photo Bond, Kuraray Medical, Inc. (2001) Summary page 1.

## Most influential descendants
- K111980: Clearfil Tri-S Bond Plus (2011), 4 descendants of its own
- K132450: Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal Bond (2013), 1 descendant of its own
- K131432: Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack; Clearfil SE Bond 2 Bond; Clearfil (2013), 1 descendant of its own
- K231696: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal (2023), 0 descendants of its own
- K192913: R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose (2021), 0 descendants of its own

## Indications for use
1) Core build-ups using light-, dual-, or self-cure composite resin 2) Direct restorations using light-cure composite resin 3) Direct restorations using self-cure composite resin 4) Cavity scaling as a pretreatment for indirect restorations 5) Treatment of exposed root surfaces 6) Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin

Source page: https://510kreport.com/device/K062382
Methodology: https://510kreport.com/methodology